topiramate

Generic: topiramate

Labeler: aurobindo pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name topiramate
Generic Name topiramate
Labeler aurobindo pharma limited
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

topiramate 25 mg/1

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 65862-171
Product ID 65862-171_cc3c1e0b-a614-4bec-8af7-8074af598df4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078462
Listing Expiration 2026-12-31
Marketing Start 2009-03-27

Pharmacologic Class

Mechanism of Action
cytochrome p450 3a4 inducers [moa] cytochrome p450 2c19 inhibitors [moa]
Physiologic Effect
decreased central nervous system disorganized electrical activity [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65862171
Hyphenated Format 65862-171

Supplemental Identifiers

RxCUI
151226 199888 199889 199890
UPC
0365862171603 0365862172600
UNII
0H73WJJ391
NUI
N0000008486 N0000185506 N0000182140

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name topiramate (source: ndc)
Generic Name topiramate (source: ndc)
Application Number ANDA078462 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 500 TABLET, FILM COATED in 1 BOTTLE (65862-171-05)
  • 60 TABLET, FILM COATED in 1 BOTTLE (65862-171-60)
  • 1000 TABLET, FILM COATED in 1 BOTTLE (65862-171-99)
source: ndc

Packages (3)

65862-171-05 500 TABLET, FILM COATED in 1 BOTTLE (65862-171-05) 65862-171-60 60 TABLET, FILM COATED in 1 BOTTLE (65862-171-60) 65862-171-99 1000 TABLET, FILM COATED in 1 BOTTLE (65862-171-99)

Ingredients (1)

topiramate (25 mg/1)

Linked Drug Pages (1)

Topiramate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "cc3c1e0b-a614-4bec-8af7-8074af598df4", "openfda": {"nui": ["N0000008486", "N0000185506", "N0000182140"], "upc": ["0365862171603", "0365862172600"], "unii": ["0H73WJJ391"], "rxcui": ["151226", "199888", "199889", "199890"], "spl_set_id": ["32b48ea0-a215-43b8-83b4-a5435a686d68"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "pharm_class_moa": ["Cytochrome P450 3A4 Inducers [MoA]", "Cytochrome P450 2C19 Inhibitors [MoA]"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (65862-171-05)", "package_ndc": "65862-171-05", "marketing_start_date": "20220411"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (65862-171-60)", "package_ndc": "65862-171-60", "marketing_start_date": "20090327"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (65862-171-99)", "package_ndc": "65862-171-99", "marketing_start_date": "20220411"}], "brand_name": "Topiramate", "product_id": "65862-171_cc3c1e0b-a614-4bec-8af7-8074af598df4", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Cytochrome P450 2C19 Inhibitors [MoA]", "Cytochrome P450 3A4 Inducers [MoA]", "Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "65862-171", "generic_name": "Topiramate", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Topiramate", "active_ingredients": [{"name": "TOPIRAMATE", "strength": "25 mg/1"}], "application_number": "ANDA078462", "marketing_category": "ANDA", "marketing_start_date": "20090327", "listing_expiration_date": "20261231"}